1. Field of the Invention
This invention relates to decompression of abdominal compartment syndrome with devices and the method of using and establishing biocompatibility for such devices.
More particularly it relates to reversing organ function impairment, venous and arterial perfusion impairment and avoiding diminishing death rates from increased intra-abdominal pressure and abdominal compartment syndrome, by temporarily expanding the envelope (fascia) that surrounds the abdominal cavity and preventing huge abdominal incisional hernias. The device is usually removed after organ function is restored when abdominal pressure has normalized and the abdomen can be closed using traditional fascia suturing techniques.
2. Description of Related Art
Increased intra-abdominal pressure or abdominal hypertension from any cause occurring acutely may lead to abdominal compartment syndrome because the abdominal cavity with its content is contained within an envelope of limited compliance. Abdominal compartment syndrome impairs functions of vital organ systems in humans and animals. Sustained abdominal hypertension above a critical value is associated with high mortality rates, which may be influenced by preexisting diseases and by physiological resources of the patient.
Therapy of abdominal hypertension is most effectively accomplished by sufficiently incising the envelope of the abdominal cavity to free intra-abdominal organs from their engorgement, and from protruding through the incision, a process that is called decompression. The critical structure of the abdominal envelope is the abdominal fascia; a sheet of fibrous tissue such as that lies deep to the skin and forms an investment of abdominal organs. The abdominal fascia has limited compliance and intra-abdominal volume expansion translates directly into pressure increases strangulating blood flow to all structures within the envelope beyond a certain threshold.
Diminished blood flow to vital organs invariably leads to tissue hypoxia and sequential organ system dysfunction and, if not treated, to death. Although the first publication about renal function impairment in the presence of abdominal hypertension was published in 1876, by E C Wendt (Arch. Heilkunde. 1876; 17:527), clinicians did not fully appreciate the condition and only recently began treating abdominal hypertension by leaving the abdomen open or provisionally covering the exposed organs with any fabric including infusion bags and meshes described in U.S. Pat. No. 4,452,245 (Schein, et al, J Am College Surg 180:745-753, 1995). Sugerman developed an external device to treat increased intra-abdominal pressure (U.S. Pat. No. 5,839,368).
Traditionally, the surgeon was always closing the abdomen by suturing the fascia. The need to treat increased intra-abdominal volumes to prevent abdominal compartment syndrome and multi-organ dysfunction was traditionally neglected until very recently when the term “abdominal compartment syndrome” was recognized as a separate clinical entity (Schein, M. et al, J Am College Surg, 180;745-753. 1995).
Upon recognition of the clinical importance of sustained acute increases in intra-abdominal volume and pressure first surgeons started just leaving the abdomen open for treatment and this technique remains the standard of care as cited in paragraph [0009]. Leaving the abdomen open, however, is invariably associated with high mortality rates, fistula formation, and large incisional hernias.
In an attempt to reduce complications other devices such as plastic meshes were used to act as fascial prostheses covering exposed abdominal organs. Plastic meshes, however, need to be reopened and often replaced for abdominal re-entry. Re-uniting the fascias is rarely possible using prior art devices and high rates of abdominal hernias develop in most cases even when meshes are used to cover the open abdomen.
The use of available meshes (U.S. Pat. No. 4,452,245) to bridge the gap between fascias is also associated with high complications and mortality rates similar to the “leaving the abdomen open” technique. In a recent publication the open abdomen technique is still advocated as the treatment of choice for abdominal compartment syndrome. (Miller, P R, J. Trauma 53:843-849, November 2002) The authors observed high intra-abdominal pressure and abdominal compartment syndrome from visceral edema in 122 of 646 patients who underwent laparotomy for trauma, and the abdomen of these 122 patients were left open after incising the fascia. More than 40% died. The authors presented a method of “late fascia closure in lieu of ventral hernia” and had to accept a high hernia rate nevertheless.
There are other conditions causing abdominal hypertension. Examples are operative manipulations, and/or excessive fluid resuscitation that may induce massive peritoneal edema increasing intra-abdominal volume while the surgeon is operating. Closing the abdomen forcefully in such situations over increased intraabdominal volumes will increase intra-abdominal pressure, and lead to multi-system organ failure and death.
As treatment progresses and edema lessens most of the prior art devices cannot accommodate decreases in abdominal distention and have to be replaced by a similar member and resutured.
There is obviously a need for a method and fascial prosthesis that expands the abdominal envelope temporarily by adding compliance to accommodate the expanded abdominal organs and structures as long as the abdominal volume increase prevails. This device should also prevent the fascias from retracting sideways to be able to re-unite them for final regular fascia-to-fascia suture when abdominal pressure has normalized without leaving foreign material in situ at the same time.
There is also a need for a method and device that reduces high mortality rates and high rates of hernia and fistula formation in patients who require treatment for abdominal hypertension reversing organ function impairment, venous and arterial perfusion impairment and abdominal compartment syndrome. The device is usually removed after organ function is restored when abdominal pressure has normalized and the fascia can be sutured by traditional techniques.
More precisely a need exists for a simple, effective, improved method and device use for decompressing abdominal hypertension, for protecting exposed abdominal organs and tissue, for opening and closing incisions without tissue damage, for permitting final fascial closure without leaving a foreign body in place, and for averting complications including infectious risks during the entire process.